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Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507311
First Posted: January 10, 2012
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Insulin secretory burst mass

Secondary Outcome Measures:
  • Insulin secretory pulse mass, amplitude, frequency and regularity
  • Insulin secretion
  • Glucagon response
  • Gastric emptying rate
  • Adverse events

Enrollment: 11
Study Start Date: September 1999
Study Completion Date: December 1999
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170 Drug: liraglutide
A single dose injected subcutaneously (under the skin)
Other Name: NNC 90-1170
Placebo Comparator: Placebo Drug: placebo
A single dose injected subcutaneously (under the skin)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months
  • BMI (Body Mass Index) between 24 and 35 kg/m^2 (both inclusive)
  • Fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
  • Anti-GAD (glutamic acid decarboxylase) negative

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Receipt of any investigational drug within three months prior to this trial
  • Recurrent severe hypoglycaemia as judged by the investigator
  • Cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
  • Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere
  • with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
  • Liver or renal disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507311


Locations
Denmark
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01507311     History of Changes
Other Study ID Numbers: NN2211-1219
First Submitted: January 6, 2012
First Posted: January 10, 2012
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists